3/31/2014 7:53:03 AM
Oxygen Biotherapeutics Inc. Provides an Update on Communication with the FDA Regarding Oxycyte Development Program
MORRISVILLE, N.C.--(BUSINESS WIRE)--March 31, 2014-- Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, announced today that it has received written confirmation from the Food and Drug Administration (FDA) that the clinical hold on the Oxycyte development program has been lifted.
In its letter to the company, the FDA reiterated what was communicated in an earlier phone conversation. They have completed their review of the September 12, 2013, submission to the investigational new drug application (IND) for Perfluorocarbon (PFC) Oxygen Carrier, Intravenous (Oxycyte). The company has satisfactorily addressed all clinical hold issues identified by the FDA and the hold has been lifted.
About Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is developing medical products for the critical care market. The company recently acquired the North American rights to develop and commercialize levosimendan. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The company also has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte(R) that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the Company's ability to successfully develop a protocol for human clinical studies that satisfies the FDA, the finalization of definitive agreements with DCRI, matters beyond the company's control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company's filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on March 17, 2014, and annual report on Form 10-K filed on June 26, 2013, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
CONTACT: IRTH Communications
Robert Haag, 1-866-976-4784
SOURCE: Oxygen Biotherapeutics, Inc.
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